Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning

November 5, 2024 updated by: Jingyi Ge, Capital Medical University

Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning:A Single-cente Randomised Controlled Trial

Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.

Study Overview

Status

Not yet recruiting

Conditions

Difficult-to-Wean Patients

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: jingyi Ge
Email: ge_jingyi2020@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),
willing to participate in the study and sign the informed consentsent.

Exclusion Criteria:

Malignant arrhythmia or acute myocardial ischemia
Pneumothorax, pulmonary bulla and barotrauma and other lung diseases
Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency
Chest skin trauma
Pulmonary hypertension and pulmonary embolism
With a permanent or temporary pacemaker
There is malignant tumor
Present and previous history of neuromuscular diseases affecting respiratory muscle
Participated in another clinical study related to mechanical ventilation withdrawal
Can not cooperate with the study for any reason or the researcher thinks that it is not suitable to be included in this experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique, positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.	Procedure: chest physiotherapy Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.
Experimental: EIT-guided group EIT-guided group: Similar to the patients in the Control group, the CPT techniques were predefined for the patients according to the assessment prior to the randomization. For each CPT session, EIT measurement was conducted and the images were used to guide the CPT treatments. The uses of EIT to guide individual treatments are briefly described as follows.	Procedure: EIT-guided chest physiotherapy EIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms.

Participant Group / Arm

Intervention / Treatment

Experimental: Control group

Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique, positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.

Procedure: chest physiotherapy

Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.

Experimental: EIT-guided group

EIT-guided group: Similar to the patients in the Control group, the CPT techniques were predefined for the patients according to the assessment prior to the randomization. For each CPT session, EIT measurement was conducted and the images were used to guide the CPT treatments. The uses of EIT to guide individual treatments are briefly described as follows.

Procedure: EIT-guided chest physiotherapy

EIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
peak expiratory flow Time Frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)	All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)

Secondary Outcome Measures

Outcome Measure	Time Frame
The cumulative incidence of successful weaning by Day 30 Time Frame: from admission to discharge, assessed up to 1 day	from admission to discharge, assessed up to 1 day
Maximum inspiratory pressure Time Frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)	All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragm thickening rate Time Frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)	All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragmatic excursion Time Frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)	All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Length of ICU stay Time Frame: from admission to discharge, assessed up to 1 day	from admission to discharge, assessed up to 1 day
Cumulative incidence for death before successful weaning Time Frame: from admission to discharge, assessed up to 1 day	from admission to discharge, assessed up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

Principal Investigator: Jingyi Ge, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 7, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

2022-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning